AccessGUDID - DEVICE: N/A (04250105604993)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 30-10-004-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 04250105604993
Issuing Agency: GS1
Commercial Distribution End Date: November 08, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use

Device Description: Quicktrach II Emergency Cricothyrotomy Set for adult

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45926	Cricothyrotomy kit, single-use	A collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTO	Tube, Tracheostomy (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K874742	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry, Keep away from sunlight and heat

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 4 Millimeter

Device Record Status

Public Device Record Key: 0e1ddb46-6252-400b-9a1a-1dd12cb6de37
Public Version Date: November 09, 2023
Public Version Number: 5
DI Record Publish Date: March 30, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
14250105604990	1	04250105604993	2023-11-08	Not in Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49745495960
Email: info@vbm-medical.de

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